A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) [amount hidden] vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

What Was Tested

The trial (phase 4) is built around Glatiramer Acetate for multiple sclerosis.

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

It had two arms (groups): Fingolimod (experimental) and Multiple Sclerosis Disease Modifying Treatments (MS DMTs) (active comparator).

Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.

The registry classes the interventions as drug.

Who Took Part

1053 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Relapsing forms of MS. Expanded Disability Status Scale (EDSS) 0-5.5. Continuous treatment with MS DMT for a minimum of 6 months.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: immune system diseases other than ms; active macular edema; history of selected prior infections and criteria for immunizations.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2010-08 with completion listed for 2012-08.

It ran at 149 sites in United States (142), Canada (6) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (time frame: Baseline, Month 6).

It also tracked 9 secondary outcomes, for example Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS), Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4, Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4, Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) and Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 1053 people with multiple sclerosis.

With 1053 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.